Methods and devices for aseptic irrigation, urine sampling, and flow control of urine from a catheterized bladder

ABSTRACT

A connector system includes a catheter connector port to attach to a urinary catheter, a urine exit port to connect to a urine collection device, an irrigation port to receive an irrigation syringe, and an internal valve. The irrigation port includes a pliable membrane that has a self-sealing opening to allow a tip of the syringe to extend therethrough. The internal valve cooperates with the syringe to shut off flow of fluid to the urine exit port when the syringe is inserted and allow for flow of fluid to the urine exit port when the syringe is removed. A distance between a proximal surface of the membrane and a distal end of the internal valve is such that the tip of the syringe can extend from a proximal end of the self-sealing opening to the distal end of the internal valve.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/747,972, titled “METHODS AND DEVICES FOR ASEPTIC IRRIGATION, URINESAMPLING, AND FLOW CONTROL OF URINE FROM A CATHETERIZED BLADDER,” filedon Jun. 23, 2015, now U.S. Pat. No. 10,076,635, which is acontinuation-in-part of U.S. patent application Ser. No. 13/414,205,titled “METHODS AND DEVICES FOR ASEPTIC IRRIGATION, URINE SAMPLING, ANDFLOW CONTROL OF URINE FROM A CATHETERIZED BLADDER,” filed Mar. 7, 2012,now U.S. Pat. No. 9,060,752, which claims the benefit under 35 U.S.C. §119 of U.S. Provisional Patent Application No. 61/464,705, titled“‘SELF-CLOSING PORT AND VALVE ASSEMBLY’ AN APPARATUS FOR IMPROVEDIRRIGATION AND DRAINAGE OF THE CATHETERIZED BLADDER,” filed Mar. 8,2011, the disclosure of which is incorporated herein by reference.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

FIELD

This invention relates to methods, systems, and apparatuses to assistwith the irrigation, urine sampling, and drainage of the catheterizedbladder, and more particularly, but not limited to, aseptic methods,systems, and apparatuses to assist with improved irrigation, urinesampling, and drainage of the catheterized bladder.

BACKGROUND

Existing urinary catheter technology results in numerous health andsafety issues for patients, medical personnel, and the community atlarge. The technology of indwelling urinary catheters has barely changedover the last 50 years. Improvements in existing urinary cathetersystems are highly desirable. A urinary catheter drainage system is madeup of the catheter itself, which is inserted into the bladder, and theurine collection device, which attaches to the catheter with tubing andcollects the urine into a receptacle. One example of a urine collectiondevice is a bedside drainage bag, which usually includes a tubeconnected to the catheter leading to a large bag that hangs on thebedside to collect the urine. Another example is a leg bag, which isworn when a patient is up and around and includes a shorter tubeattached to a smaller bag that is attached to the leg and collectsurine.

The complications associated with catheterization of the bladder includecatheter associated urinary tract infections (CAUTI's), blockage (due tostruvite or biofilm formation), bladder atony (causing a short term orpermanent inability to void), bladder spasms, and thickening of thebladder wall from long term use.

In addition to direct patient complications, there are numerous safetyissues related to current urinary catheter systems, both in theinpatient setting and in the home health setting. Present systems putclinicians at risk of occupational injury related to bio-hazardous wasteexposure. Clinicians are frequently sprayed with urine when attemptingto irrigate clogged catheters, such as when pressure from the irrigationsyringe causes swelling of the catheter and spray back to occur. Becausethe current available catheter technology demands that the catheter bedisconnected from the urine collection device in order to irrigate thesystem, leaking or spilling of urine often occurs during theseprocedures. When these spills and splashes occur, clinicians, otherpatients, and the community at large are put at risk for crosscontamination and the spread of infection, including antibioticresistant pathogens.

In summary, most of the problems listed above arise, at least in part,from two primary problems with existing catheter systems: (1) Currentcatheter systems do not allow for the maintenance of a closed, asepticsystem; and (2) Current catheter systems do not allow the bladder tofill and empty in a normal fashion.

About 30% of CAUTI's are shown to be caused by intraluminal bacterialbiofilm formation. The primary way that bacteria enter the inner lumento cause infection is by entering the drainage end of the catheter andascending the inner lumen to the bladder. The 2009 CDC HealthcareInfection Control Practices Advisory Committee (HICPAH) listed a closedurinary drainage system for all catheters as a high priorityrecommendation, essential for all healthcare organizations caring forpatients with catheters. They found both older and more recent dataindicating that disconnection of the urine collection device from thecatheter is a risk factor for bacteriuria.

In order to maintain a closed urinary drainage system, the cathetergenerally should not be disconnected from the urine collection device.The most common reason for disconnecting the catheter from the urinecollection device is when the catheter needs to be irrigated. Manycatheters need to be irrigated several times a day, requiringdisconnection of the catheter from the urine collection device andexposing the patient to infection and the clinician to bio-hazardouswaste repeatedly.

In order to address the specific problem associated with closedirrigation of a catheter, Russo U.S. Patent Application Pub. No. US2006/0064065 discloses a closed system irrigation connector for urinarycatheters includes a silicone diaphragm that opens when an irrigationdevice is attached and closes when it is removed. However, the device ofRusso does not provide for an aseptic irrigation procedure. In order tomaintain an aseptic closed system, anything entering the system shouldbe free of bacteria. This means that the system would ideally haveentrance portals that are closed while not being accessed and that arefully sanitizable prior to access.

In order to effectively sanitize a surface, the surface should be easilyand fully accessible to apply the needed friction and anti-infectiveagent. The surface should not have crevices or difficult to reachplaces, as asperities, steps and other such features can trap bacteriaand grow biofilm while remaining shielded from the sanitizing effects ofthe alcohol swab. The plastic entrance port disclosed by Russo does nothave a flat, easily sanitizable surface, but has a crevice that cannotbe effectively sanitized. Bacteria hiding on this un-sanitizable surfacecan enter the system during irrigation and infect the patient.

The second major problem with current catheter systems is that theydrain the bladder constantly, not allowing it to fill and empty in anormal manner. This leaves a pool of concentrated, stagnant urine in theneck of the bladder below the drainage holes on the catheter. Thisstagnant urine serves to create a perfect breeding ground for bacteria.Catheter blockage is another problem with “constant drain” cathetersystems and is caused by the buildup of biofilm and salt crystals at theopening of the catheter. Much like a stalactite, the high pH, highmineral fluid in the neck of the bladder provides the perfectenvironment for this to occur. Bladder spasms can be caused by severalfactors associated with constant drain systems. The most frequent causeis CAUTI, as already discussed above. With CAUTI, the bladder wallbecomes irritated and even swells, causing spasms. The loss of normalstretching and contracting of the detrusor can also cause spasms.Irritation from highly concentrated and high pH urine can also befactor. Bladder wall thickening has also been observed in long-termcatheterizations and may be a result of the increasing retention ofurine. Catheter-related bladder atony is another complication associatedwith not allowing the bladder to fill and empty. When the bladder nolonger fills and empties in a normal fashion, the detrusor muscle canatrophy, causing a temporary or even permanent inability to void aftercatheterization. These problems could be solved, at least in part, byallowing the bladder to fill and drain in a more normal fashion.

Many types of valved catheters and universal connections exist thatallow for intermittent draining and retention of the bladder. None ofthe prior art in this area discloses sanitizable surfaces on entry portsleading from the outside to the inside of the closed urinary drainagesystem. These prior art systems thus often complicate the problem byintroducing bacteria into what should be a closed system. A system,method, and apparatus is needed that allows for aseptic irrigation andurine sampling while maintaining a closed system, while allowing forcontrol of urine flow, permitting the bladder to fill and empty asneeded or prescribed.

Moreover, disconnection of the urine collection device from the catheteris also desirable for many practical reasons, even if not required foraseptic irrigation and sampling. For example, the need to disconnect theurine collection device arises in the following situations, which canoccur several times per day:

-   -   1. When the drainage bag needs to be replaced with a new bag.    -   2. When a patient changes the clothing or underclothing on the        lower part of their body.    -   3. When a patient switches from a bedside urinary drainage bag        to a leg drainage bag or vice versa.    -   4. When it is desirous to temporarily disconnect a urinary        collection device from the catheter portion of the system for        tests, transfers, bathing and numerous other purposes.    -   5. When a patient must have a urinary catheter but desires to        avoid being connected a urinary collection device for a given        time period.

In order to reuse a urine collection device once it has beendisconnected from the system, the connecting end of the urine collectiondevice has to be fully protected from contamination and not come intosurface contact with any other non-aseptic surface per the principles ofasepsis. It is not adequate to simply swab an exposed unprotected end ofa urine collection device that was disconnected from the system with adisinfectant prior to reconnection to the catheter end. This is becausethe urine collection device is open at the connection end, and bacteriacan enter the inside of the urine collection device, which is notsanitizable. Reusable protective covers or sheaths are currentlyemployed to cover the connecting end of the urine collection device whenit has been disconnected from the catheter end of the system. However,these reusable covers are generally not adequate and tend to lead tocontamination of the system. This is because the covers can becontaminated in between uses and are not sanitizable on the insidesurface that comes into contact with the connecting end. As a result,the covers can introduce bacteria to the surface of the connecting endof the urine collection device.

An improved connector system is therefore needed to allow for asepticdisconnection and reconnection of the urine collection device from thecatheter in all of the above circumstances while maintaining a closedurinary drainage system under these circumstances.

It is therefore desirable to provide an improved urinary drainageconnector system that allows for aseptic disconnection and reconnectionof the urine collection device from the catheter, in addition to asystem that obviates the need for disconnection duringirrigation/sampling.

SUMMARY OF THE DISCLOSURE

Systems, methods, and apparatuses for improved aseptic irrigation, urinesampling, and flow control of urine from the catheterized bladder aredisclosed. The disclosed invention, also referred to for the purposes ofeasy reference only, as a port and valve assembly, allows for asepticirrigation and urine sampling of the catheterized bladder withoutdisconnecting the catheter from the drainage bag by including asanitizable self-closing port and allowing for bypassing of the drainagebag during irrigation. An irrigation syringe, irrigating device, orurine sampling device can be inserted into a self-closing port on theapparatus to irrigate or urine sample the bladder without disconnectionof the catheter from the urine collection device, and the bladder can beirrigated or urine sampled while maintaining a closed, aseptic system.When the syringe is removed, the port closes. The flat closed surface ofthe port is easily sanitizable with standard medical sanitizer, such as70% alcohol, so bacteria cannot enter the system when a device isattached. This allows for aseptic access to the interior of the urinarycatheter system so that irrigation can be performed withoutcontamination of the urinary drainage system by bacteria or exposure tobody fluids and infectious waste.

Another aspect of the invention employs an inner mechanism thatprohibits shuts the flow of fluid to the urine collection device whilean irrigation syringe, irrigation device, or collection device isinserted in the port. This mechanism allows for effective irrigation andurine sampling of the catheter and bladder without fluid or air beingshunted into, or pulled from, the drainage collection device. Shuttingflow off from the urine collection device is essential for irrigating acatheter that is attached to the urine collection device. If not done,fluid would flow into the collection device and not the catheter beingirrigated. The system disclosed herein makes the collection of urinesamples easy by sealing the urine collection device end, allowing forsuction of urine from the bladder.

In yet another aspect, within some embodiments of the present invention,the system and apparatus has an externally controlled mechanism to shutoff the flow of urine from the bladder to the urine collection devicefor a prescribed adjustable period of time, enabling the bladder to filland empty in a more normal fashion. This feature is important because itallows clinicians to set the amount of time for bladder filling, withoutworrying about releasing the urine at a particular time, an importantsafety and convenience feature. This feature also allows for bladdertraining of patients, allowing for increased increments of time in whichthe bladder can fill with urine, thus slowly training the bladder tohold more urine before needing to empty.

The improved utilities of the present invention can decrease the chanceof urinary tract infection or bladder atony, decrease the risk of bloodand body fluid exposure, and greatly simplify the procedure of bladderirrigation of the catheterized patient.

One aspect of the invention provides a urinary catheter connector systemhaving a housing, a catheter connector port supported by the housing andconfigured to attach to a urinary catheter, a urine exit port supportedby the housing and configured to connect to a urine collection device,an irrigation port supported by the housing and configured to receive anirrigation syringe, a channel in the housing fluidly connecting thecatheter connector port, the urine exit port and the irrigation port,and a valve supported by the housing and adapted to cooperate with theirrigation syringe to shut off flow of fluid and air to the urine exitport when the irrigation syringe is inserted and allow for flow of fluidand air to the urine exit port when the irrigation syringe is removed.In some embodiments, the valve has a first position in which the urinecollection device is in fluid communication with the catheter connectorport and a second position in which the urine collection device is notin fluid communication with the catheter connector port. The valve maybe biased to the first position by, e.g., a spring. The valve may alsobe adapted to be moved from the first position to the second position bya syringe tip inserted into the irrigation port.

In some embodiments, the valve includes a thickening in the wall of thehousing, wherein the thickening decreases the diameter of the channeland is configured to approximate the size of the tip of an irrigationsyringe and to mate snugly with the irrigation syringe. When theirrigation syringe is inserted into the valve, the urine collectiondevice is not in fluid communication with the catheter connector port,and when the syringe is not inserted in the valve opening, the urinecollection device is in fluid communication with the catheter connectionport. In some embodiments, the valve has a valve seat adapt to mate withan exterior surface of the irrigation syringe to shut off the flow offluid and air to the urine exit port when the irrigation syringe isinserted and allow for the flow of fluid and air to the urine exit portwhen the irrigation syringe is removed.

Some embodiments of the invention also include a valve control mechanismadapted to move the valve from the first position to the second positionwithout inserting a device into the irrigation port. The valve controlmechanism may be adapted to automatically permit the valve to move fromthe second position to the first position after a time period withoutoperator intervention. In some embodiments, the valve control mechanismincludes a compliant balloon.

Some embodiments of the invention have a valve control mechanism with acompliant balloon adapted to be inflated to close the valve. Some suchembodiments also include a compressible fluid-filled actuation chamber,first and second passages connecting the actuation chamber with theinterior of the balloon, and a one-way valve disposed in the firstpassage to permit fluid flow from the actuation chamber into the balloonand block fluid flow from the balloon into the actuation chamber. Thevalve control mechanism may also have a syringe port adapted to permitinflation of the balloon by a syringe.

Some embodiments of the invention also have a pliable membrane extendingover the irrigation port. The membrane has a self-sealing openingadapted to permit insertion of a syringe tip. In some embodiments, theirrigation port has an exterior surface that is flat and completelyexposable to friction applied with a medical sanitizing agent so thatthe irrigation port is fully sanitizable. The irrigation port mayconnect to the channel between the catheter connection port and theurine exit port.

Another aspect of the invention provides a method of irrigating aurinary catheter, including the steps of: draining urine from anindwelling urinary catheter through a catheter connector port, achannel, and out through a urine exit port; simultaneously opening anirrigation port and closing off flow to the urine exit port; andinjecting irrigation fluid through the irrigation port, the channel, thecatheter connector port and into the catheter. In some embodiments, theirrigation port surface is sanitized prior to insertion of theirrigation syringe. In some embodiments, the method also includes thestep of simultaneously closing the irrigation port and opening the urineexit port, thereby allowing urine to drain from the indwelling urinarycatheter through the channel and out the urine exit port.

In some embodiments, the step of simultaneously opening the irrigationport and closing the urine exit port includes the step of moving a valvefrom a first position in which the urine exit port is in fluidcommunication with the catheter connector port to a second position inwhich the urine exit port is not in fluid communication with thecatheter connector port. The moving step may include the step of movingthe valve with a distal tip of a syringe. The method may also includethe step of inserting the syringe through a self-sealing opening in theirrigation port.

In some embodiments, the step of simultaneously opening the irrigationport and closing the urine exit port includes the step of inserting asyringe through the irrigation port and into a valve. In some suchembodiments, the step of simultaneously opening the irrigation port andclosing the urine exit port further includes the step of seating anoutside surface of the syringe in a valve seat of the valve.

Yet another aspect of the invention provides a method of operating aurinary catheter system including the following steps: establishing flowof urine from an indwelling urinary catheter through a connector andinto a drainage bag; actuating a valve to stop the urine flow; andpermitting the valve to automatically open after a time period withoutoperator intervention.

In some embodiments, the actuating step includes the step of expanding aballoon to block flow through the connector. In some embodiments, thepermitting step includes the step of permitting the balloon to deflate.In some embodiments, the expanding step includes the step of compressinga valve actuation chamber. In some embodiments, the expanding stepincludes the step of injecting fluid into the balloon with a syringe.

Still another aspect of the invention provides a method of operating aurinary catheter system including the following steps: establishing flowof urine from an indwelling urinary catheter through a connector andvalve opening and into a urine drainage connector; inflating a balloonmanually to stop the urine flow through the valve opening and drainageconnector; and deflating the balloon manually to allow urine to flowthrough the valve opening and drainage connector.

Yet another aspect of the invention provides a urinary catheter system,including a urinary catheter port, a urine exit port, an irrigation portconfigured to receive an irrigation syringe, a channel connecting theurinary catheter port, urine exit port and irrigation port, and a valveadapted to cooperate with the irrigation syringe to shut off flow offluid and air to the urine exit port when the irrigation syringe isinserted and allow for flow of fluid and air to the urine exit port whenthe irrigation syringe is removed.

In general, in one embodiment, a urinary catheter connector systemincludes a housing, a catheter connector port, a urine exit port, anirrigation port, a channel in the housing, and an internal valve. Thecatheter connector port is supported by the housing and is configured toattach to a urinary catheter. The urine exit port is supported by thehousing and is configured to connect to a urine collection device. Theirrigation port is supported by the housing and is configured to receivean irrigation syringe. The irrigation port includes a pliable membraneextending thereover. The pliable membrane has a self-sealing openingtherein configured to allow a tip of the irrigation syringe to extendtherethrough. The channel fluidly connects the catheter connector port,the urine exit port, and the irrigation port. The internal valve issupported by the housing and adapted to cooperate with the irrigationsyringe to shut off flow of fluid and air to the urine exit port whenthe irrigation syringe is inserted and allow for flow of fluid and airto the urine exit port when the irrigation syringe is removed. Adistance between a proximal surface of the membrane and a distal end ofthe internal valve is selected such that the tip of the irrigationsyringe can extend from a proximal end of the self-sealing opening tothe distal end of the internal valve when the irrigation syringe isinserted into the irrigation port.

This and other embodiments can include one or more of the followingfeatures. The internal valve can include a thickening in the wall of thehousing. The thickening can decrease the diameter of the channel and canbe configured to approximate the size of the tip of the irrigationsyringe and to mate snugly with the irrigation syringe. When theirrigation syringe is inserted into the internal valve, the urinecollection device may not be in fluid communication with the catheterconnector port, and when the syringe is not inserted into the internalvalve, the urine collection device may be in fluid communication withthe catheter connector port. The internal valve can include a valve seatadapted to mate with an exterior surface of the irrigation syringe toshut off the flow of fluid and air to the urine exit port when theirrigation syringe is inserted and allow for the flow of fluid and airto the urine exit port when the irrigation syringe is removed. Theproximal surface of the pliable membrane can be flat and completelyexposable to friction applied with a medical sanitizing agent so thatthe irrigation port is fully sanitizable. The irrigation port canconnect to the channel between the catheter connection port and theurine exit port. The pliable membrane can be without crevices. A pliablemembrane can extend over the urine exit port. The pliable membrane ofthe urine exit port can have a self-sealing opening therein configuredto allow a tip of the urine collection device connector to extendtherethrough. The pliable membrane of the irrigation port can be smoothand uniform. The system can further include an internal valve supportedby the housing at the urine exit port that is configured to allow flowof liquid through the urine exit port when open and to prohibit the flowof fluid therethrough when closed.

In general, in one embodiment, a urinary catheter connector systemincludes a housing, a catheter connector port, a urine exit port, anirrigation port, and a channel. The catheter connector port is supportedby the housing and is configured to attach to a urinary catheter. Theurine exit port is supported by the housing and is configured to connectto a urine collection device. The urine exit port includes a firstpliable membrane extending thereover. The first pliable membrane has aself-sealing opening therein configured to allow a tip of a urinecollection device connector to extend therethrough. The irrigation portis supported by the housing and is configured to receive an irrigationsyringe. The irrigation port includes a second pliable membraneextending thereover. The second pliable membrane has a self-sealingopening therein configured to allow a tip of the irrigation syringe toextend therethrough. A channel in the housing fluidly connects thecatheter connector port, the urine exit port, and the irrigation port.

The urinary connector system can further include an internal valvesupported by the irrigation port housing and adapted to cooperate withthe irrigation syringe to shut off flow of liquid to the urine exit portwhen the irrigation syringe is inserted and allow for flow of liquid tothe urine exit port when the irrigation syringe is removed. The systemcan further include an adaptor including a proximal end configured toremovably attach to the urine collection device and a distal end thatincludes the urine collection device connector. The adaptor can includea housing with a sanitizable slit membrane disposed over the distal end.The adaptor can include a sleeve covering the urine collection deviceconnector. The sleeve can be configured to retract to expose the urinecollection device connector. The sleeve can include accordion ortelescoping features configured to allow the sleeve to retract. Theurinary connector system can further include an internal valve supportedby the urine exit port housing and adapted to cooperate with the tip ofthe urine collection device connector to allow flow of liquid throughthe urine exit port into the urine collection device when open and toshut off flow of liquid to the urine exit port when closed. The internalvalve can include an external feature configured to allow manualactivation of the valve. The internal valve can be a spring valve or aflap valve. The system can further include a rigid cap configured tocover and mate with the tip of the urine collection device connector.The rigid cap can be configured to be removed from the urine collectiondevice connector for insertion of the connector into the urine exit portand to be replaced when the connector is removed from the urine exitport. The rigid cap can further include a slit-valve positioned over aproximal end of the rigid cap to seal an inner space within the rigidcap.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe claims that follow. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1 is an illustration of a self-closing port and valve assemblyaccording to one embodiment of the invention showing an irrigatingsyringe inserted into a self-closing port and bypassing the urinecollection device through means of a valve, which closes flow to theurine collection device when the irrigation device is attached.

FIG. 2 is an illustration of a self-closing port and valve assemblyshowing the device of FIG. 1 without an irrigating syringe inserted intothe self-closing port. Here, the valve is open, and urine can flow intothe urine collection device.

FIG. 3 is an illustration of a preferred embodiment of a self-closingport and valve assembly according to another embodiment of theinvention. Here, there is no irrigating syringe inserted into theself-closing port, and urine can flow into the urine collection device.

FIG. 4 is an illustration of a self-closing port and valve assemblyshowing the device of FIG. 3 with an irrigating syringe inserted intothe self-closing port and bypassing the urine collection device throughmeans of a valve that closes flow to the urine collection device.

FIG. 5 is a detail of a port and valve assembly showing one embodimentof an optional valve actuator being used with the assembly shown inFIGS. 1 and 2.

FIGS. 6A and 6B show another embodiment of an optional valve actuatorbeing used with the assembly shown in FIGS. 3 and 4.

FIG. 7 is a flow diagram showing an aseptic port access procedure forirrigating or collecting a urine specimen from a port and valveassembly.

FIG. 8 is a cross section of one embodiment of a port and valve assemblyhaving a sanitizable self-closing port with flexible valve body at theurine exit port. The urine collection device connector is not connectedto the port.

FIG. 9 is a cross section of the same embodiment of FIG. 8 showing theurine collection device connector connected to the port.

FIGS. 10A and 10B are cross sections of one embodiment of a sheath witha sanitizable slit membrane for protecting the connecting end of aurinary collection device when it is disconnected from the catheter endof the system. FIG. 10A shows the connecting end of the urinarycollection device not attached to the sheath. FIG. 10B shows theconnecting end of the urinary collection device attached to andprotected within the sheath.

FIGS. 11A-11C show an adaptor configured to mate to the urinarycollection device and also configured to provide a compatible matingfeature for the port and valve assembly. FIG. 11A shows the adaptorconnected to the urinary collection device and covering the end of thedevice. FIG. 11B shows the adaptor connected to the urinary collectionsystem and in its retracted state ready for connection to the port andvalve assembly. FIG. 11C shows the adaptor connected to both the urinarycollection device and the port and valve assembly.

FIGS. 12A and 12B show an alternate embodiment of the adaptor with aretractable protective sheath. FIG. 12A shows the adaptor connected tothe urinary collection device and covering the end of the device, andFIG. 12B shows the adaptor connected to the urinary collection system inits retracted state ready for connection to the port and valve assembly.

FIGS. 13A-13B show one embodiment of a port and valve assembly having aninternal valve within the urine exit port. FIG. 13A shows the valveclosed, while FIG. 13B shows the valve open.

DETAILED DESCRIPTION

The following description and drawings are illustrative and are not tobe construed as limiting. Numerous specific details are described toprovide a thorough understanding. However, in certain instances, wellknown or conventional details may not be described in order to avoidobscuring the description. In accordance with the present invention, anovel and improved system for aseptic irrigation and urine specimencollection and/or for disconnection of urine collection device from acatheterized bladder is provided.

The devices, systems, and methods described herein solve the problem ofdisconnection and potential exposure to contaminants during irrigationand urine sampling by providing a port valve assembly that attaches atone port to the catheter, at a second port to the urinary collectiondevice, and at a third port to an irrigation/sampling syringe. Some orall of the ports can be protected by slit membranes. The slit membranesdescribed herein can advantageously be sanitized by swabbing 70% alcoholor other medical disinfectant across its surface prior to the sterileirrigation/sampling or the urine collection device connector syringeentering the system, thus providing for aseptic means to: (1) irrigatethe catheter or sample urine without disconnecting the urine collectiondevice during the irrigation/sampling; and/or (2) disconnect andreconnect the urine collection device. The slit membranes can closeautomatically after removal of the syringe or urine collection deviceconnector, leaving the system closed and aseptic.

In some embodiments described herein, the port and valve assembly caninclude three ports. The first port connects directly to the catheter.

The second port, the urine exit port, connects to the urinary collectiondevice. The second contains a valve that opens when the urinarycollection device is connected and closes, shutting off fluidcommunication with the outside, when the urine collection device isdisconnected from the port. The second port of the assembly can beprotected by a slit membrane. The slit membrane ensures that thecatheter side of the drainage system remains aseptically closed. It canbe sanitized by swabbing 70% alcohol or other medical disinfectantacross its surface. The outer surface of the slit membrane assembly isdesigned to be smooth, uniform, and free of crevices so that it can befully sanitized. By placing a swabbable slit membrane on the urine exitport of the port and valve assembly, the urinary collection device canbe disconnected and a closed aseptic system is preserved on the catheterend. In the preferred embodiment, the swabbable slit membrane isdesigned to also serve as the valve on the port. In other embodiments,the slit membrane is just protective, and the valve function (i.e.,allowing fluid to flow in and out of the port) is provided by aninternal valve.

The third port of the assembly, the irrigation and sampling port,contains a valve that closes fluidic communication with the collectionsystem when an irrigation/sampling syringe is inserted into the port.The third port can also protected by a slit membrane. The third port'sslit membrane can be sanitized by swabbing 70% alcohol or other medicaldisinfectant across its surface prior to the sterile irrigation/samplingsyringe entering the system, thus providing for aseptic means toirrigate the catheter or sample urine without disconnecting the urinecollection device during the irrigation/sampling. Upon removal of thesyringe, fluidic communication with the urine exit port is automaticallyre-established, and the slit membrane closes automatically, leaving thesystem closed, without fluidic communication to the outside.

Other embodiments can include few valves or ports and/or the valvedassembly can be used with an adaptor that provides a connection betweenthe urine collection device and the port and valve assembly.

FIGS. 1 and 2 are illustrations of a self-closing port and valveassembly 10 according to one embodiment of the present invention. Withinthis embodiment, the device has a fully sanitizable self-closingirrigation port 12 that allows a urinary catheter to remain attached toa urine collection device while being irrigated without disconnectingthe urine collection device drainage tubing 14 from the urinary catheter(not shown). This allows for an aseptic, closed system, which keepsbacteria from entering the catheter and also prevents exposure to bodyfluids during the irrigation or sampling process.

The self-closing port and valve assembly 10 can be located in numerousplaces on a urinary catheter drainage system. For instance, it can be apart of a urinary catheter itself. It can be a separate device thatconnects between the catheter and the drainage bag. It can be a part ofthe urine collection device. In the embodiment of FIGS. 1 and 2, theassembly is a part of the urine collection device and is located at thejunction between the catheter connector port 7 in the catheter connector11 and the urine exit port 8 in the drainage tube 14, which drains urinefrom the catheter into the urine collection device.

In the embodiment of FIGS. 1 and 2, an internal valve 15 has a tensionspring 17. The spring tension keeps the internal valve biased in a firstposition, in which a urine exit channel 18 is open to the urine drainagetube 14. Spring 17 can be, for example, a torsion spring, leaf spring orany other spring or spring-like element. Insertion of a catheter tip,irrigation syringe, or other similar device 13 into the self-closingirrigation port 12 pushes the internal valve 15 to a second positionagainst the urine exit port to the urine collection device drainage tube14, closing it off and bypassing any flow to the drainage tube whilekeeping the irrigation port open.

In the present embodiment, the valve 15 is fashioned so that a portionof it protrudes into the path of a device 13 inserted into theself-closing irrigation port 12. The device inserted into the portpushes the protruding portion of the valve in the direction of the urineexit port, closing the valve when the device is inserted into theirrigation port. This automatically shuts off the flow of fluid and airto the drainage bag, allowing for irrigation of the catheter and bladderwithout the irrigation fluid entering the drainage tube. When theirrigation procedure is complete and the syringe 13 is removed, thespring 17 moves the valve back to the open position to allow urine toflow from the catheter, into the urine collection device and to thedrainage collection receptacle.

In the embodiment of the device in FIGS. 1 and 2, the port and valveassembly 10 also has a valve control mechanism 16 to externally shut thevalve 15 without the insertion of a syringe or other object into theport 12. This would allow the valve 15 to be closed even when notirrigating or collecting samples from the catheter. Keeping the valveclosed would stop the flow of urine from the bladder to the urinecollection device drainage tube 14 and allow the bladder to fill withurine, an important physiological function that is normally inhibited instate of the art urinary catheter systems. In some embodiments, thevalve control mechanism 16 may be designed in such a way as to allow forthe valve to stay closed for a specific prescribed and adjustable amountof time, allowing for the bladder to fill for a prescribed amount oftime and then empty when that time period ends. Examples of the valvecontrol mechanism are described below.

FIG. 3 is an illustration of an alternative embodiment of the port andvalve assembly 10′. In FIG. 3, a syringe is not inserted through aself-closing port, and fluid 20 is free to flow through an internalvalve 31 through an opening in the valve 30. In FIG. 4, the flow offluid to the drainage bag is shut off when an irrigation syringe isinserted into the port and valve assembly by means of an internal valve31, which mates with the tip of the irrigation syringe when inserted.The tip of the irrigation syringe fits snugly into the internal valve,sealing flow of fluid or air from the drainage bag.

The internal valve 31 in the embodiment of FIG. 3 and FIG. 4 is made bya thickening in the wall of the port and valve assembly, which decreasesthe diameter of the channel, forming the valve opening 30. The internalvalve 31 created by the thickened wall may, in some embodiments, belined with a flexible material, such as foam, latex, or silicone, toform a valve seat 32 adapted to cooperate with an exterior surface ofthe syringe. When an irrigation device is inserted through theirrigation port, it enters the valve opening, and the syringe compressesthe expandable material 32 lining the internal valve. The syringe isheld tightly in place by this compression and creates an air and fluidseal.

Referring to FIG. 3, the irrigation port 12 can include a self-sealingmembrane 9 made of latex or other highly flexible and pliable materialextending thereover. The membrane 9 is smooth and uniform (i.e., flat orwithout crevices), thereby making the entire surface (includingattachment points to the port 12) smooth and uniform. Further, themembrane 9 has a small pliable hole within in the center that runs fromthe external portion of the membrane 9 to the internal portion of themembrane 9. When a syringe or other irrigation device is pushed againstthe external portion of the membrane 9, the pliable hole 23 spreadsopen, and the irrigation device can be passed through the membrane 9 tothe internal portion of the port. When the syringe is removed, the hole23 closes tightly, forming a seal that keeps urine in and bacteria outof the urinary drainage system. The smooth and uniform surface of theport 12 is easily sanitizable with 70% alcohol or other standard medicalsanitizer, allowing for aseptic port access without introduction ofbacteria into the drainage system. FIG. 7 is a flow diagram of anaseptic port access procedure.

The embodiment of the valve control mechanism shown in FIG. 5 consistsof a small compliant balloon 21 which is inflated by an air filledchamber 22 that is made of a soft compressible material. By applyingpressure to the air filled chamber manually, typically with the push ofa finger or thumb, air is squeezed out of the chamber and into theballoon, which, in turn, closes the valve stopping the flow of urine outof the bladder. The chamber is fashioned in such a way as to allow airto pass without resistance into the balloon through a one way valve 24.Once inside the balloon, the air must pass through a block 27 in whichone or more holes form a balloon deflation orifice. The time period overwhich balloon 21 deflates can be controlled by the size and/or number ofholes in block 27, which allows for control of the amount of time thevalve 15 stays open. The air passes through the block and out the airexit hole 26.

FIG. 6 is an illustration of an embodiment of a valve control mechanismfor use with the port and valve assembly of FIGS. 3 and 4. This figuredemonstrates how the balloon 21 inflates to close off the flow of fluidfrom the catheter to the drainage bag by blocking flow from the opening30 to the urinary drainage end of the port and valve assembly.

In other embodiments, the balloon may be inflated by other means, suchas a syringe. FIGS. 6A and 6B show one embodiment of the port and valveassembly, in which the compliant balloon is inflated by a syringe 28.Air or fluid is introduced into the balloon by the syringe, whichattaches onto a luer locking connection 29 that has a valve 61 attachedto a spring 62. When the syringe is attached, it pushes prongs 63 on thesurface of valve 61, depressing the valve and spring and opening a fluidconnection between the syringe and balloon cavity 64. When the syringeis removed, the spring pushes the valve closed, sealing the compartmentand trapping the air or fluid within the balloon, keeping it inflated.In order to restart the flow of urine from the bladder to the urinarydrainage bag, a syringe is simply re-attached to the luer locking portand the air or fluid is removed from the balloon.

In some embodiments, the air in the balloon slowly leaks out through adifferent air passage 26 from which it entered and through a block 27with one or more holes, as described above. The valve control mechanism16 in some embodiments may employ a lever instead of a balloon thatpushes the valve shut.

In some embodiments, the port and valve assembly described herein canfurther include a slit-valve on the urine collection port. Referring toFIG. 8, a connector 10 includes, in addition to the self-closing slitmembrane 9 of the irrigation and sampling port 12, a self-closingslit-valve 40 on the urine exit port 8 at the proximal end of the urineexit channel 18. The slit-valve 40 is similar in function and design tothe slit membrane on port 12 and is likewise a fully sanitizableself-closing valve extending over the port 8. The valve 40 thus includesa smooth and uniform membrane 49 having a hole or slit 43 therein.Further, an internal mating mechanism 45, such as a frusto-conicaltapered mating mechanism made from a thickening of the port wall or alocking ring and taps, can be configured to mate with a distal end ofthe urine collection device 46.

In use, the slit-valve 40 remains closed when the urinary collectiondevice is disconnected, keeping the urinary catheter end of the systemclosed, and its sanitizable feature allows for aseptic re-connection ofa urinary collection device 46. When the connecting end of a urinarycollection device 46 is inserted into the slit 43 in the center of theslit-valve 40, the slit 43 opens by stretching around the connectingend. When fully inserted, the urinary connection device mates with theinternal mating mechanism 45, which holds the connecting end firmly inthe housing body until the user desires to disconnect the urinarycollection device 46 from the catheter portion of the system. Theslit-valve 40 and the internal mating mechanism 45 thus help to maintainan air and fluid tight seal. FIG. 9 illustrates a connected urinarycollection device 46 attached to the connection 10 such that urine canflow (in direction of the arrow 44) into the urine collection device 46.

Further, referring to FIGS. 13A and 13B, in some embodiments, aninternal valve 63, such as a spring valve or flap valve, can bepositioned within the urine exit port 8 and be configured to allow urineto flow therethrough when open and to block the flow of urine whenclosed. In some embodiments, the internal valve 63 can be activated whenthe distal tip of the urine collection device 46 is insertedtherethrough. In other embodiments, the internal valve can be configuredto be activated manually to open or close the valve. For example, asshown in FIGS. 13A-13B, the valve can include an external dial 65 that,when rotated, can move the valve from closed (FIG. 13A) to open (FIG.13B). For example, the internal valve 63 can be a stop cock or adeformable valve that, when squeezed orthogonally, opens the valve.Having an externally controlled valve 63 can advantageously allow thepatient to close the valve when disconnecting from the urine collectiondevice 46, but still open the valve when the patient wants to void intothe toilet. In some embodiments, the internal valve 63 and theslit-valve 40 can be combined such that external activation of theinternal valve opens the slit valve.

In some embodiments, a protective sheath or cap can be provided to covera distal end of the urine collection device, i.e. the portion configuredto connect to the assembly 10. FIG. 10A shows one embodiment of aprotective sheath 57. The protective sheath 57 can include a rigidcylindrical housing 50 and an inner compartment 54 having a matingmechanism 55 configured to mate with a distal end of the urinecollection device 46. Further, the mating mechanism 55 can be, forexample, a frusto-conical tapered mating mechanism made from athickening of the housing wall or a locking ring and taps. A slit-valve51 can cover the proximal end of the cylindrical housing 50 to seal theinner compartment 54. The protective slit valve 51 can be similar inform and function to the valve 40 on the port and valve assembly, and assuch, can be fully sanitizable and self-closing. Thus, when the urinecollection device is not connected to the urine exit port 8 of the portand valve assembly 10 described herein, the connecting end of the urinecollection device 46 can be inserted into the protective sheath 57 bypushing it through the slit-valve 51. The distal end of the device 46can then mate with the inner compartment 54, where it can be maintainedin an aseptic environment.

To aseptically disconnect the urine collection device 46 from the urineexit port 8 of the port and valve assembly 10 and connect it to theprotective sheath 57 (e.g., to replace the drainage bag, etc.), thefollowing steps are involved. Using aseptic techniques to assure nocontamination of the device during transfer, the user first sanitizesthe protective sheath slit-valve 51 with medical sanitizer. Next, theuser disconnects the urine collection device 46 from the urine exit port8 of the port and valve assembly 10 by pulling it proximally. Theslit-valve 40 shuts tightly once the distal end of the urine collectiondevice 46 is fully removed. The user can then push the distal edge ofthe urine collection device 46 against the slit-valve 51 to cause theslit 52 therein to open by expansion. The slit-valve 51 can maintain atight seal around the distal end of the urine collection device 46,keeping the interior of the protective sheath closed off from theoutside environment and aseptic. When the connecting end of the urinarycollection device 46 is fully inserted into the protective sheath 57, itmates with mechanism 55 to hold the urinary collection device 46 firmlyinside the protective sheath 57 until the user desires to remove it.When the user desires to disconnect the connecting end of the urinecollection device 46 from the protective sheath 57 and connect to theurine exit port 8 of the port and valve assembly 10, the same basicprocess as above can be followed, first sanitizing the urine exit portslit-valve 40, disconnecting the connecting end of the urine collectiondevice 46 from the sheath 57, and pushing the connecting end of theurine collection device 46 against the aseptic surface of valve 40 andinto the assembly 10.

In some embodiments, an adaptor can be used to connect the distal end ofthe urinary collection device 46 to the assembly 10, thereby allowingone single optimized design of a port and valve assembly to be connectedto various urinary collection devices even if the mating feature of theurinary collection device varies. The adaptor can be attached to theurine collection device to ensure compatibility between the collectiondevice's connector and the port and valve assembly.

FIGS. 11A-C show an exemplary adaptor 80 configured to mate with boththe distal end of a urinary collection device 46 and the urine exit port8 of the port and valve assembly 10. The adaptor 80 can thus include afirst connector 75 configured to mate with the distal end of the urinecollection device 46 and a second connector 76 configured to mate withthe urine exit port 8. The connectors 75, 76 can be, for example,frusto-conical tapered mating mechanisms or locking rings and taps. Theadaptor 80 can further include a protective sheath 73 that extends overthe connector 76. The sheath 73 can include accordion features orbellows 74 that enable the sheath 73 to retract when connected with theurine exit port 8 is desired. The material forming the bellows 74 can bemade of a plastic, such as medical grade vinyl (PVC) or polyurethane,that has enough elasticity to allow the accordion to bend at its folds.The adaptor 80 can further include a protective slit membrane 70 thatprotects the adaptor mating tip of the second connector 76 and keeps itaseptic when the adaptor 80 is not connected to the port and valveassembly 10, as shown in FIG. 11A. FIG. 11B illustrates the adaptor 80with the sheath 73 in its retracted state ready for connection, and FIG.11C illustrates the adaptor 80 connected to the port and valve assembly10, with connector 76 connected to the port 8.

In use, the adaptor 80 can be provided sterile to the user. Further, theadaptor 80 can be connected to the urinary collection device 46 uponfirst use and not disconnected from this junction throughout its use.The adaptor 80 advantageously allows for intermittent connection betweenthe adaptor 80 and the port 8, keeping the urinary collection device 46of the system aseptic when it is disconnected from the port and valveassembly 10. The only time the connector 76 is exposed to the outside ofthe system is when exposed for insertion into the urine exit port 8.This brief exposure can be performed using aseptic techniques, whichwhen properly done, can ensure that the connector 76 is not exposed toany other contaminated surface. With the use of the slit membraneadaptor 80, the urinary collection device 46 is not exposed to theenvironment and is therefore protected from contamination whetherdisconnected or connected to the port and valve assembly 10.

FIGS. 12A-12B illustrates another exemplary adaptor 90. The adaptor 90is similar to adaptor 80 except that retraction of the sheath 73 isprovided by two rigid housings 72, 78 that are slidable relative to oneanother, i.e., in a telescoping fashion. A cylindrical connector 77made, for example, of an elastic material or film, such as latex orpolyurethane, can connect the distal end of the inner cylinder 72 withthe proximal end of the outer cylinder 78. As shown in FIG. 12B, whenthe outer cylinder 78 moves proximally to expose the connector 76, thecylindrical connector 77 can stretch or unroll to maintain connectionbetween the two cylinders 72, 78, thereby ensuring that no contaminantscan get in between the cylinders 72, 78.

The sterile adaptors 80, 90 described herein can have multiple purposes.For example, the adaptor can advantageously ensure compatibility of theurine exit port of the port and valve assembly with the mating featureon the urinary collection device. The port and valve assembly can thenbe manufactured with a single connector design, while the adaptor can becustomized for different potential types of urine collection deviceconnectors (both present and future). The adaptor can alsoadvantageously prevent contamination of the urine collection devicewhile it is disconnected from the system.

In some embodiments, the port and valve assembly described herein isoptimized such that patients can intermittently open the valve and slitmembrane on the urine exit port to allow for discharge of urine from thecatheter and bladder when a urine collection device is not used. Thiscan be done by an internal mechanism that aseptically opens the urineexit port valve and slit membrane to allow for drainage, for example astopcock valve that also splays open the slit membrane when open. Inanother embodiment, the features of the slit membrane and valve can becombined into a polymeric slit-valve that can be actuated by the patientto allow for urine discharge, for example by squeezing the slit-valve ina direction orthogonal to the slit. The patient could then void directlyinto the toilet, for example. Intermittent drainage from a slit-valve atthe urine exit port of the port and valve assembly can also be achievedby insertion of a sterile external device into the urine exit port thatallows for drainage. Packs of disposable sterile drainage tubes can beprovided along with the port and valve assembly for situations when aurinary collection device is not used.

In some embodiments of the connector system, the inside walls of theport and valve assembly and/or of the adaptor may contain a coating thatis saturated with an antiseptic agent such as nitrofurazone, silversalt, or other agent, as an added means of defense againstmicro-organism contamination. The contamination resistant coating maycontain geometric features to deter biofilm formation, such as fractalpatterns in the surface microstructure. In some embodiments, thecontamination resistant features may be contained in the structuralmaterial itself, such as silver-containing micro-particles mixed intoplastic.

The ports described herein can be configured to be large enough toconnect to irrigation syringes and/or the typical connectors found inurinary drainage systems. For example, the ports can have a diameter ofbetween ¼ inch and ½ inch, such as between ⅜ inch and 5/16 inch. Thesediameters can be larger than would be required for use, for example,with parenteral connectors.

Embodiments of the connector system here are shown as configured suchthat the catheter connection port and the irrigation and sampling portare in-line with one another along a central axis while the urinarycollection port is orthogonal (approximately 90 degrees) to the centralaxis. This configuration can advantageously make irrigation and samplingmore intuitive to the user and can allow the assembly to be attached tothe patient so that gravity will drain urine into the urinary collectiondevice. For example, for supine in-bed use, the assembly can be tapedsuch that the in-line catheter connection and irrigation/sampling portsare along the leg, and the 90 degree drain from the urine exit port canbe pointed toward the floor. In primarily ambulatory patients using aurine drainage bag, the assembly can be taped such that the urine exitport points down to the leg to the ground.

Advantageously, the systems, methods, and devices described herein candecrease the chance of urinary tract infection or bladder atony,decrease the risk of blood and body fluid exposure, greatly simplify theprocedure of bladder irrigation, and allow for connection anddisconnection of the urine collection device from the catheter end ofthe urinary drainage system while maintaining a closed aseptic systemfrom the connecting end of the urine collection device to the bladder.The systems, methods, and devices described herein can also improve thequality of life of patients by allowing them more freedom from the urinecollection device, allowing them to wear a catheter more discreetlyduring social interactions or when out of their home. Moreover, thesystems, methods, and devices can improve the quality of life forcaregivers who manage patients' catheters by making use of the devicemuch easier and safer.

It will be apparent to a skilled artisan that the embodiments describedherein are exemplary of inventions that may have greater scope than anyof the singular descriptions presented. There may be alterations made inthese examples without departing from the spirit and scope of theinvention disclosed. For example, any aspect of an improved asepticurinary drainage device and system may have components with differentshapes or designs within different embodiments. For instance, springtypes, housing shape, valve diameter and compositions may vary in designfrom one embodiment to another, but not overall function. In someembodiments, the catheter connection port may be the drainage end of aurinary catheter. In some embodiments, the urine exit port may be anintrinsic part of the urine collection device, and in some embodimentsthe port and valve assembly may be separate from the urine collectiondevice. These or other features may change in different embodiments. Insome embodiments, the shape or dimensions of the valves or mating andconnection features may change, the housing shape, valve diameter andcompositions may vary in design from one embodiment to another, but notin overall function.

What is claimed is:
 1. A method of irrigating a urinary cathetercomprising: draining urine from an indwelling urinary catheter through acatheter connector port, a channel and out through a urine exit port;simultaneously opening an irrigation port and closing off flow to theurine exit port; and injecting irrigation fluid through the irrigationport, the channel, the catheter connector port and into the catheter. 2.The method of claim 1, wherein the irrigation port surface is sanitizedprior to insertion of the irrigation syringe.
 3. The method of claim 1,further comprising simultaneously closing the irrigation port andopening the urine exit port, thereby allowing urine to drain from theindwelling urinary catheter through the channel and out the urine exitport.
 4. The method of claim 1, wherein the step of simultaneouslyopening the irrigation port and closing the urine exit port comprisesmoving a valve from a first position in which the urine exit port is influid communication with the catheter connector port to a secondposition in which the urine exit port is not in fluid communication withthe catheter connector port.
 5. The method of claim 4, wherein themoving step comprises moving the valve with a distal tip of a syringe.6. The method of claim 5, further comprising inserting the syringethrough a self-sealing opening in the irrigation port.
 7. The method ofclaim 1, wherein the step of simultaneously opening the irrigation portand closing the urine exit port comprises inserting a syringe throughthe irrigation port and into a valve.
 8. The method of claim 7, whereinthe step of simultaneously opening the irrigation port and closing theurine exit port further comprises seating an outside surface of thesyringe in a valve seat of the valve.
 9. A method of operating a urinarycatheter system comprising: establishing flow of urine from anindwelling urinary catheter through a connector and into a drainage bag;actuating a valve to stop the urine flow; and permitting the valve toautomatically open after a time period without operator intervention.10. The method of claim 9, wherein the actuating step comprisesexpanding a balloon to block flow through the connector.
 11. The methodof claim 10, wherein the permitting step comprises permitting theballoon to deflate.
 12. The method of claim 10, wherein the expandingstep comprises compressing a valve actuation chamber.
 13. The method ofclaim 10, wherein the expanding step comprises injecting fluid into theballoon with a syringe.
 14. A method of operating a urinary cathetersystem comprising: establishing flow of urine from an indwelling urinarycatheter through a connector and valve opening and into a urine drainageconnector; inflating a balloon manually to stop the urine flow throughthe valve opening and drainage connector; and deflating the balloonmanually to allow urine to flow through the valve opening and drainageconnector.